Have any underlying medical condition, psychiatric condition, or social situation that, in the opinion of the Investigator, would compromise study administration as per protocol or compromise the assessment of AEs.
Has any history or medical condition, metastatic condition, drug/medication use or other condition that might, per protocol or in the opinion of the investigator, compromise:
Any underlying medical condition, psychiatric condition or social situation that in the opinion of the investigator would compromise study administration as per protocol or compromise the assessment of adverse events (AEs)
Any underlying medical condition, psychiatric condition or social situation that in the opinion of the investigator would compromise study administration as per protocol or compromise the assessment of adverse events (AEs)
Has history of any disease, metastatic condition, drug/medication use or other condition that might, per protocol or in the opinion of the investigator, compromise:
Have any underlying medical condition, psychiatric condition, or social situation that, in the opinion of the Investigator, would compromise study administration as per protocol or compromise the assessment of AEs.
Patient receiving concomitant therapy, which in the opinion of the Investigator is considered relevant for the evaluation of the efficacy or safety of the trial drug.
Any condition or illness that, in the opinion of the investigator, would compromise patient safety or interfere with the evaluation of the drug
Any other concomitant serious illness or organ system dysfunction in opinion of Investigator would either compromise subject safety or interfere with test drug safety evaluation
Any condition or illness that, in the opinion of the investigator, would compromise patient safety or interfere with the evaluation of the drug
Any other concomitant serious illness or organ system dysfunction which in the opinion of the investigator would either compromise patient safety or interfere with the evaluation of the safety of the study drug
Other medical or psychiatric illness or organ dysfunction which, in the opinion of the Investigator, would either compromise the subject's safety or interfere with the evaluation of the safety of the study agent.
Any history of or concomitant condition that, in the opinion of the investigator, would compromise the patient’s ability to comply with the study or interfere with the evaluation of the efficacy and safety of the test drug
Any history of or concomitant condition that, in the opinion of the investigator, would compromise the patient’s ability to comply with the study or interfere with the evaluation of the efficacy and safety of the test drug
Other medical or psychiatric illness or organ dysfunction, which in the opinion of the investigator, would either compromise the subject's safety or interfere with the evaluation of the safety of the study agent
Uncontrolled concomitant disease that in the opinion of the investigator would interfere with the patient’s safety or compliance on trial
History of severe autoimmune disease that in the opinion of the investigator would interfere with patient safety or compliance on trial
Other medical or psychiatric illness or organ dysfunction or laboratory abnormality which, in the opinion of the investigator, would compromise the subject’s safety or interfere with data interpretation
Has any serious concomitant illness that in the opinion of the investigator(s) could affect the participant's safety or interfere with the study assessments.
Have any condition or illness that, in the opinion of the investigator would compromise patient safety or interfere with evaluation of the study drug (including but not limited to human immunodeficiency virus [HIV] and hepatitis C virus [HCV])
Have any condition or illness that, in the opinion of the investigator, might compromise patient safety or interfere with the evaluation of the safety of the drug
Any history of or concomitant condition that, in the opinion of the investigator, would compromise the patient’s ability to comply with the study or interfere with the evaluation of the efficacy and safety of the test drug
History or evidence on physical examination or screening laboratory tests of any systemic disease or any acute or chronic illness that, in the opinion of the investigator, may interfere with the evaluation of the safety or immunogenicity of the study drug
Any illness or condition that in the opinion of the investigator may affect safety of treatment or evaluation of any the study’s endpoints
Have any condition or illness that, in the opinion of the investigator, might compromise patient safety or interfere with the evaluation of the safety of the drug.
Has any serious concomitant illness that in the opinion of the investigator(s) could affect the participant's safety or interfere with the study assessments
Patients who have any other life threatening illness or organ system dysfunction, which in the opinion of the investigator, would either compromise patient safety or interfere with the evaluation of the safety of the study drug
Any other illness or condition that the treating investigator feels would interfere with study compliance or would compromise the patient’s safety or study endpoints
Any serious active disease or co-morbid condition, which in the opinion of the principal investigator, will interfere with the safety or compliance of the trial
Patients must not have any other concomitant serious illness or organ system dysfunction which in the opinion of the investigator would either compromise patient safety or interfere with the evaluation of the safety of the study drug
Have any condition or illness that, in the opinion of the investigator, would compromise patient safety or interfere with the evaluation of the study drug.
Any other illness or condition that the treating investigator feels would interfere with study compliance or would compromise the patient’s safety or study endpoints
Any illness or condition that in the opinion of the investigator may affect safety of treatment or evaluation of any the study’s endpoints
Have any condition or illness that, in the opinion of the investigator, would compromise participants safety or interfere with evaluation of the drug study.
Other medical or psychiatric illness or organ dysfunction or laboratory abnormality which in the opinion of the investigator would compromise the patient’s safety or interfere with data interpretation
Other laboratory abnormalities that, in the opinion of the investigator, would compromise the patient’s safety or interfere with data interpretation
Other medical or psychiatric illness or organ dysfunction that, in the opinion of the investigator, would either compromise the patient’s safety or interfere with the evaluation of the safety of bevacizumab
Suffer from any other condition or illness that would compromise safety or interfere with evaluation of the drug
Other medical or psychiatric illness or organ dysfunction or laboratory abnormality which in the opinion of the investigator would compromise the patient’s safety or interfere with data interpretation, e.g., infection/inflammation, intestinal obstruction, unable to swallow medication, social/ psychological issues, etc.
Suffer from any condition or illness that, in the opinion of the investigator, would compromise patient safety or interfere with the evaluation of the safety of the study drug
Any illness or condition that in the opinion of the Investigator may affect safety of treatment or evaluation of any the study’s endpoints
Any history of or concomitant condition that, in the opinion of the investigator not to comply with the study or interfere with the evaluation of the efficacy and safety of the test drug
Patients with any other life-threatening illness, significant organ system dysfunction, or clinically significant laboratory abnormality, which, in the opinion of the Investigator, would either compromise the patient's safety or interfere with evaluation of the safety of the study drug.
Patients with any other life-threatening illness, significant organ system dysfunction, or clinically significant laboratory abnormality, which, in the opinion of the Investigator, would either compromise the patient's safety or interfere with evaluation of the safety of the study drug
Other medical or psychiatric illness or organ dysfunction or laboratory abnormality which in the opinion of the investigator would compromise the patient’s safety or interfere with data interpretation
Psychiatric or cognitive illness or recreational drug/alcohol use that, in the opinion of the principal investigator, would affect patient safety and/or compliance.
Systemic cardiac disease that would, in the opinion of the investigator or medical monitor, interfere with assessment of efficacy or safety of the drug
any other concomitant serious illness or organ system dysfunction which in the opinion of the investigator would either compromise subject safety or interfere with the evaluation of the safety of the test drug
Subject has another active medical condition(s) or organ disease(s) that may either compromise subject safety or interfere with the safety and/or outcome evaluation of the study drug
Any other medical condition, which in the opinion of the Investigator, places the subject at an unacceptably high risk for toxicities.
The patient has any medical condition which in the opinion of the Investigator places the patient at an unacceptably high risk for toxicities.
Subjects may not receive ABBV-399 in combination with erlotinib or nivolumab if they have any medical condition which in the opinion of the Investigator places the subject at an unacceptably high risk for toxicities from the combination.
Any medical condition which in the opinion of the study investigator places the subject at an unacceptably high risk for toxicities
Any condition presenting an unacceptably high anesthetic or surgical risk
Participant has any medical condition which in the opinion of the investigator places the participant at an unacceptably high risk for toxicities.
Clinically significant and uncontrolled major medical condition(s) that places the\n subject at an unacceptably high risk for toxicities. These include, but are not\n limited to: active infections, symptomatic pulmonary disease, inadequate pulmonary\n function, seizure disorder, psychiatric illness.
The patient has any medical condition which in the opinion of the investigator places the patient at an unacceptably high risk for toxicities.
The patient has any medical condition which, in the opinion of the Investigator, places the patient at an unacceptably high risk for toxicities.
Any medical condition which in the opinion of the investigator places the participant at an unacceptably high risk for toxicities.
No other medical, or psychosocial problems, which in the opinion of the primary physician or principal investigator would place the patient at unacceptably high risk from this treatment regimen
Any medical condition, which in the opinion of the study Investigator, places the participant at an unacceptably high risk for toxicities
Any medical condition, which in the opinion of the study investigator, places the subject at an unacceptably high risk for toxicities;
The patient has any medical condition which in the opinion of the Investigator places the patient at an unacceptably high risk for toxicities.
Subject has any medical condition which in the opinion of the investigator places the subject at an unacceptably high risk for toxicities.
Clinically significant and uncontrolled major medical conditions including but not limited to: active uncontrolled infection, psychiatric illness/ social situation that would limit compliance with study requirements; any medical condition, which in the opinion of the study investigator places the subject at an unacceptably high risk for toxicities
Medical, psychiatric, cognitive or other conditions that compromise the patient's ability to understand the patient information, to give informed consent, to comply with the study protocol or to complete the study.
Any serious medical or psychiatric illness that could, in the investigator’s opinion, potentially compromise the patient’s ability to understand the patient information, to give informed consent, to comply with the treatment according to this protocol or complete the study
Uncontrolled intercurrent illness including medical, psychiatric, cognitive or other conditions, psychiatric illness/social situations that would compromise the patient's ability to understand the patient information, to give informed consent, to comply with the study protocol or to complete the study or, in the judgment of the principal investigator, would make the patient inappropriate for study participation
Significant medical psychiatric cognitive or other conditions that may compromise the patient ability to understand the patient information to give informed consent to comply with the study protocol or to complete the study
Medical, psychiatric, cognitive or other conditions that may compromise the patient's ability to understand the patient information, give informed consent, comply with the study protocol or complete the study
Medical, psychiatric, cognitive or other conditions that may compromise the patient's ability to understand the patient information, give informed consent, comply with the study protocol or complete the study
Medical, psychiatric, cognitive or other conditions that may compromise the patient's ability to understand the patient information, give informed consent, comply with the study protocol or complete the study
Medical or psychiatric conditions that compromise the subject's ability to give informed consent or to complete the protocol or a history of non-compliance
Has any medical, psychiatric, cognitive, or other conditions that may compromise the participant's ability to understand the participant information, give informed consent, comply with the study protocol, or complete the study.
Medical, psychiatric, cognitive or other conditions that may compromise the patient's ability to understand the patient information, give informed consent, comply with the study protocol or complete the study
Medical, psychiatric, cognitive or other conditions that may compromise the patient's ability to understand the patient information, give informed consent, comply with the study protocol or complete the study
Medical, psychiatric, cognitive or other conditions that compromise the patient's ability to understand the patient information, to give informed consent, to comply with the study protocol or to complete the study or, in the judgment of the investigator, would make the patient inappropriate for study participation
Medical, psychiatric, cognitive or other conditions that may compromise the patient's ability to understand the patient information, give informed consent, comply with the study protocol or complete the study
Significant medical, psychiatric, cognitive or other conditions that may compromise the patient's ability to understand the patient information, to give informed consent, to comply with the study protocol, or to complete the study
Medical, psychiatric, cognitive or other conditions that may compromise the patient's ability to understand the patient information, give informed consent, comply with the study protocol or complete the study
Research participants with other clinically significant medical disorders that could compromise their ability to tolerate protocol therapy or would interfere with the study procedures or results history
Patients with any significant medical illnesses that in the investigator’s opinion cannot be adequately controlled with appropriate therapy or would compromise the patient’s ability to tolerate this therapy
Patients with any clinically significant unrelated systemic illness (serious infections or significant cardiac, pulmonary, hepatic or other organ dysfunction), that would compromise the patient’s ability to tolerate protocol therapy, put them at additional risk for toxicity or would interfere with the study procedures or results
Patients that have any significant medical illnesses that in the investigator’s opinion cannot be adequately controlled with appropriate therapy or would compromise the patient’s ability to tolerate this therapy are excluded
Any significant medical illnesses or infection that, in the investigator’s opinion, cannot be adequately controlled with appropriate therapy or would compromise the patient’s ability to tolerate this therapy are not eligible for participation
Patients with any clinically significant unrelated systemic illness that would compromise the patient’s ability to tolerate protocol therapy
Patients with any clinically significant unrelated systemic illness (serious infections or significant cardiac, pulmonary, hepatic or other organ dysfunction) that will likely interfere with the study procedures or results
Concurrent Illness\r\n* Patients with active autoimmune disease or documented history of autoimmune disease/syndrome that requires ongoing systemic steroids or systemic immunosuppressive agents, except \r\n** Patients with vitiligo or resolved asthma/atopy\r\n** Patients with hypothyroidism stable on hormone replacement or Sjogren’s syndrome \r\n* History of or ongoing pneumonitis or significant interstitial lung disease\r\nNote: This would include non-infectious pneumonitis that required steroid use\r\n* Patients with any clinically significant unrelated systemic illness (serious infections or significant cardiac, pulmonary, hepatic or other organ dysfunction), that in the opinion of the investigator would compromise the patient’s ability to tolerate protocol therapy, put them at additional risk for toxicity or would interfere with the study procedures or results\r\n* Patients with other current malignancies\r\n* Patients with known hypermutated brain tumors including those with CMMRD and Lynch syndrome are ineligible for enrollment in Strata A, B, D and E\r\n* Patients who have received a solid organ transplant
EXCLUSION CRITERIA FOR STRATUM C: Concurrent illness\r\n* Patients with active autoimmune disease or documented history of autoimmune disease/syndrome that requires ongoing systemic steroids or systemic immunosuppressive agents, except \r\n** Patients with vitiligo or resolved asthma/atopy\r\n** Patients with hypothyroidism stable on hormone replacement or Sjogren’s syndrome \r\n* History of or ongoing pneumonitis or significant interstitial lung disease\r\n* Note: This would include non-infectious pneumonitis that required steroid use\r\n* Patients with any clinically significant unrelated systemic illness (serious infections or significant cardiac, pulmonary, hepatic or other organ dysfunction), that in the opinion of the investigator would compromise the patient’s ability to tolerate protocol therapy, put them at additional risk for toxicity or would interfere with the study procedures or results\r\n** Exception to this is the presence of gastrointestinal polyps/adenomas and non-metastatic carcinomas, and history of any previous malignancies in patients with CMMRD which will be allowed in this study\r\n* Patients who have received a solid organ transplant
Patients with any clinical significant unrelated systemic illness (serious infections or significant cardiac, pulmonary, hepatic or other organ dysfunction) that is likely to interfere with the study procedures or results
Patients that have any significant medical illnesses that in the investigator’s opinion cannot be adequately controlled with appropriate therapy or would compromise the patient’s ability to tolerate this therapy are excluded
Clinically significant patient history which in the judgment of the principal investigator would compromise the patient’s ability to tolerate high-dose
Clinically significant unrelated systemic illness (serious infections or significant cardiac, pulmonary, hepatic or other organ dysfunction), which in the judgment of the principal or associate investigator would compromise the patient’s ability to tolerate this therapy or are likely to interfere with the study procedures or results
Clinically significant patient history which in the judgment of the principal investigator (PI) would compromise the patients’ ability to tolerate high-dose aldesleukin.
STRATUM A: Participants with other clinically significant medical disorders (serious infections or significant cardiac, pulmonary, hepatic, psychiatric, gastrointestinal [GI] disease, or other organ dysfunction) that in the investigator’s judgment could compromise their ability to tolerate or absorb protocol therapy or would interfere with the study procedures or results
STRATUM B: Participants with other clinically significant medical disorders (serious infections or significant cardiac, pulmonary, hepatic, psychiatric, GI disease, or other organ dysfunction) that in the investigator’s judgment could compromise their ability to tolerate or absorb protocol therapy or would interfere with the study procedures or results
STRATUM C: Participants with other clinically significant medical disorders (serious infections or significant cardiac, pulmonary, hepatic, psychiatric, GI disease, or other organ dysfunction) that in the investigator’s judgment could compromise their ability to tolerate or absorb protocol therapy or would interfere with the study procedures or results
Clinically significant patient history which in the judgment of the principal investigator (PI) would compromise the patients’ ability to tolerate high-dose aldesleukin; (Note: At the discretion of the PI, patients enrolled in cohort 3 may receive low-dose aldesleukin)
Patients with any significant medical illnesses that in the investigator’s opinion cannot be adequately controlled with appropriate therapy or would compromise the patient’s ability to tolerate this therapy
Patients with any clinically significant unrelated systemic illness (serious infections or significant cardiac, pulmonary, hepatic or other organ dysfunction), likely interfere with the study procedures or results
Any medical or psychiatric illness, which, in the opinion of the principal investigator, would compromise the patient's ability to tolerate this treatment
Patients must not have any significant medical illnesses that in the investigator’s opinion cannot be adequately controlled with appropriate therapy or would compromise the patient’s ability to tolerate this therapy.
Patients must not have any significant infections or medical illnesses that in the investigator’s opinion cannot be adequately controlled with appropriate therapy or would compromise the patient’s ability to tolerate NU-0129
Clinically significant medical disorders that could compromise the ability to tolerate protocol therapy or that would interfere with the study procedures or results history
Patients with clinically significant unrelated systemic illness (including autoimmune disease, serious infections or significant cardiac, pulmonary, hepatic or other organ dysfunction) which in the judgment of the principal or associate investigators would compromise the patient’s ability to tolerate this therapy or are likely to interfere with the study procedures or results
Patients must not have any significant medical illnesses that in the investigator’s opinion cannot be adequately controlled with appropriate therapy or would compromise the patient’s ability to tolerate this therapy
Patients who exhibit any significant concurrent, uncontrolled medical or psychiatric condition that in the opinion of the investigator would compromise the patient's ability to tolerate this treatment are NOT eligible for participation
Any medical or psychiatric illness which in the opinion of the principal investigator would compromise the patient’s ability to tolerate this treatment
Clinically significant systemic illness (e.g. serious active infections or significant cardiac, pulmonary, hepatic or other organ dysfunction), that in the judgment of the principal investigator (PI) would compromise the patient’s ability to tolerate protocol therapy or significantly increase the risk of complications
Patients with any significant medical illnesses that in the investigator’s opinion cannot be adequately controlled with appropriate therapy or would compromise the patient’s ability to tolerate this therapy
Patients has any significant medical illnesses that in the investigator’s opinion cannot be adequately controlled with appropriate therapy or would compromise the patient’s ability to tolerate this therapy
Patients with any clinically significant unrelated systemic illness (serious infections or significant cardiac, pulmonary, hepatic or other organ dysfunction), that in the opinion of the investigator would compromise the patient’s ability to tolerate protocol therapy, put them at additional risk for toxicity or would interfere with the study procedures or results
Patients with any significant medical illnesses that, in the investigator’s opinion, cannot be adequately controlled with appropriate therapy or would compromise the patient’s ability to tolerate this therapy
Any significant medical illnesses or toxicities that in the investigator’s opinion cannot be adequately controlled with appropriate therapy or would compromise the subjects’ ability to tolerate this therapy. Subjects must not have any disease that will obscure toxicity or dangerously alter drug metabolism, e.g. congestive heart failure, moderate to severe liver and renal disease, other cancers.
Concurrent Illness\r\n* Patients with any clinically significant unrelated systemic illness (serious infections grade >= 2 or significant cardiac, pulmonary, hepatic or other organ dysfunction), that in the opinion of the investigator would compromise the patient’s ability to tolerate protocol therapy, put them at additional risk for toxicity or would interfere with the study procedures or results\r\n* Patients with a history of any other malignancy, except patients with a secondary brain tumor if the patient’s first malignancy has been in remission for at least 5 years from the end of treatment
Clinically significant systemic illness (e.g. serious active infections or significant cardiac, pulmonary, hepatic or other organ dysfunction), that in the judgment of the principal investigator (PI) would compromise the patient’s ability to tolerate protocol therapy or significantly increase the risk of complications
Patients with significant medical illness that in the investigator’s opinion cannot be adequately controlled with appropriate therapy or would compromise the patient’s ability to tolerate this therapy
Clinically significant systemic illness (e.g., serious active infections or significant cardiac, pulmonary, hepatic or other organ dysfunction), that in the judgment of the principal investigator (PI) would compromise the patient’s ability to tolerate protocol therapy or significantly increase the risk of complications; peripheral nerve symptoms from prior therapies or from tumor compression > grade 1
Any medical or psychiatric illness, which in the opinion of the principal investigator, would compromise the patient's ability to tolerate this treatment or limit compliance with study requirements
Clinically significant systemic illness (e.g. serious active infections or significant cardiac, pulmonary, hepatic or other organ dysfunction), that in the judgment of the PI would likely compromise the patient’s ability to tolerate protocol therapy or significantly increase the risk of complications
Any medical or psychiatric illness, which, in the opinion of the principal investigator, would compromise the patient’s ability to tolerate this treatment
Clinically significant unrelated illness which would, in the judgment of the treating physician, compromise the patient's ability to tolerate the investigational agent or be likely to interfere with the study procedures or results.
Concurrent Illness Patients with any clinically significant unrelated systemic illness (serious infections or significant cardiac, pulmonary, hepatic or other organ dysfunction) that would compromise the patient's ability to tolerate protocol therapy or would likely interfere with the study procedures or results.
Any significant medical illnesses that in the investigator's opinion cannot be adequately controlled with appropriate therapy or would compromise the patient's ability to tolerate this therapy
Patients with any clinically significant systemic illness, including serious infection, pulmonary, hepatic, or other organ impairment, that would compromise tolerance and/or timely completion of protocol therapy
Patients with any clinically significant unrelated systemic illness (e.g., serious infections or significant cardiac, pulmonary, hepatic or other organ dysfunction), that in the opinion of the investigator would compromise the patient’s ability to tolerate protocol therapy, put them at additional risk for toxicity or would interfere with the study procedures or results
Patients must not have any significant medical illnesses that in the investigator’s opinion cannot be adequately controlled with appropriate therapy or would compromise the patient’s ability to tolerate this therapy
Patients with any significant medical illnesses or infection that, in the investigator’s opinion, cannot be adequately controlled with appropriate therapy or would compromise the patient’s ability to tolerate this therapy are not eligible for participation
Research participants with other clinically significant medical disorders that could compromise their ability to tolerate protocol therapy or would interfere with the study procedures or results
Known severe, active co-morbidity, defined as follows:\r\n* Any clinically significant unrelated systemic illness, medical condition, or other factor, which at the discretion of the Principal Investigators, would interfere in the safe and timely completion of study procedures, compromise the patient’s ability to tolerate the protocol therapy, or is likely to interfere with the study procedures or results
Patients must be ineligible to receive IL-2 based on evidence that may include ischemic heart disease, or arrhythmias, or poor ventricular ejection fraction (< 50%), or respiratory compromise (forced expiratory volume in one second [FEV1] < 60%), or prolonged smoking history, or clinically significant patient history which in the judgment of the investigator would compromise the patient’s ability to tolerate aldesleukin
Patients must not have any significant medical or psychiatric illnesses that in the investigator's opinion cannot be adequately controlled with appropriate therapy or would compromise the patient's ability to tolerate this therapy.
Patients must not have any significant medical illnesses that, in the investigator's opinion, cannot be adequately controlled with appropriate therapy or would compromise the patient's ability to tolerate this therapy
Clinically significant systemic illness with manifestations of significant organ dysfunction which in the judgment principal investigator (PI) or associated investigator (AI) would render the patient unlikely to tolerate the protocol therapy or complete the study
Patients must not have any significant medical illnesses that in the investigator's opinion cannot be adequately controlled with appropriate therapy or would compromise the patient's ability to tolerate this therapy
Patients must not have any significant medical illnesses that in the investigator's opinion cannot be adequately controlled with appropriate therapy or would compromise the patient's ability to tolerate this therapy
Medical or psychiatric condition which in the opinion of the protocol chairman would compromise the patient's ability to tolerate this protocol
Clinically significant unrelated systemic illness (serious infections or significant cardiac, pulmonary, hepatic or other organ dysfunction) which in the judgment of the Principal or Associate Investigator would compromise the patient’s ability to tolerate PEG-Intron or are likely to interfere with the study procedures or results
Patients with any clinically significant unrelated systemic illness (serious infections or significant cardiac, pulmonary, hepatic or other organ dysfunction), that would compromise the patient’s ability to tolerate protocol therapy or would likely interfere with the study procedures or results
Clinically significant systemic illness (e.g. serious active infections or significant vital other organ dysfunction), that in the judgment of the principal investigator (PI) would likely compromise the patient’s ability to tolerate protocol therapy or significantly increase the risk of complications
RECURRENT/ PROGRESSIVE DIPG (STRATUM 1): Patients have any clinically significant unrelated systemic illness (serious infections or significant cardiac, pulmonary, hepatic or other organ dysfunction), that in the opinion of the investigator would compromise the ability of the patient to tolerate protocol therapy or put them at additional risk for toxicity or would interfere with the study procedures or results
NON-PROGRESSED DIPG (STRATUM 2): Patients have any clinically significant unrelated systemic illness (serious infections or significant cardiac, pulmonary, hepatic or other organ dysfunction), that in the opinion of the investigator would compromise the ability of the patient to tolerate protocol therapy or put them at additional risk for toxicity or would interfere with the study procedures or results
Patients who have serious intercurrent medical illness which in the opinion of the investigator would compromise the patient's ability to tolerate this therapy
Any medical or psychiatric illness which, in the opinion of the principal investigator, would compromise the patient's ability to tolerate this treatment regimen
Patients with any clinically significant unrelated systemic illness (serious infections or significant cardiac, pulmonary, hepatic or other organ dysfunction), that would compromise the patient’s ability to tolerate protocol therapy or would likely interfere with the study procedures or results
Clinically significant untreated system illness, such as seriously infections, autoimmunity or organ dysfunction, which in the judgement of the Principal or Associate Investigators would compromise the patient’s ability to tolerate the investigational agents or are likely to interfere with the study procedures or results
Clinically significant unrelated systemic illness, such as serious infections or organ dysfunction, which in the judgement of the Principal or Associate Investigators would compromise the patient’s ability to tolerate the investigational agents or are likely to interfere with the study procedures or results
Clinically significant unrelated systemic illness, such as serious infections or organ dysfunction, which in the judgment of the Principal or Associate Investigators would compromise the patient’s ability to tolerate the investigational agents or are likely to interfere with the study procedures or results
Patients must not have any significant medical illnesses that in the investigator's opinion cannot be adequately controlled with appropriate therapy or would compromise the patient's ability to tolerate this therapy
Patients must not have any significant medical illnesses that in the investigator’s opinion cannot be adequately controlled with appropriate therapy or would compromise the patient’s ability to tolerate this therapy
Patients with clinically significant illnesses which, according to the Investigator, could compromise participation in the study;
Any significant medical or psychiatric illness that cannot be adequately controlled with appropriate therapy or would compromise the patient’s ability to tolerate therapy, per the discretion of the treating investigator
Patients must not have any significant medical illnesses that in the investigator’s opinion cannot be adequately controlled with appropriate therapy, would compromise the patient’s ability to tolerate the imaging examination or any disease that will obscure toxicity or dangerously alter response to the imaging agent
Has signs, symptoms or history of any condition that, per protocol or in the opinion of the investigator, might compromise:
Any history of a medical condition or a concomitant medical condition that, in the opinion of the investigator, would compromise the subject's ability to safely complete the study
Any other serious concomitant medical condition that, in the opinion of the investigator, would compromise the safety of the participant or compromise the participant's ability to participate in the study
Any disease or condition that, in the opinion of the Investigator, would compromise the safety of the patient or interfere with study assessments.
Serious concomitant systemic disorders (e.g., active uncontrolled infection or uncontrolled diabetes) or psychiatric disorders that, in the opinion of the investigator, would compromise the safety of the patient or compromise the patient's ability to complete the study.
Any other condition which, in the opinion of the investigator, may compromise the subject's ability to follow study procedures and safely complete the study
No serious disease or condition that, in the opinion of the investigator, would compromise the patient’s ability to participate in the study
Has had major surgery (other than definitive lung cancer surgery) within two weeks of study or other serious concomitant disorders that in the opinion of the investigator would compromise the safety of the patient or compromise the patient’s ability to complete the study
Subject has any medical or psychiatric condition that, in the opinion of the Investigator, may compromise the subject's ability to participate in this study
Any medical condition, which in the investigator's opinion, could compromise the patient's safety
Has any other medical or personal condition that, in the opinion of the site investigator, may potentially compromise the safety or compliance of the patient, or may preclude the patient’s successful completion of the clinical trial
Any other medical intervention or condition, which, in the opinion of the PI or treating physician, could compromise patient safety or adherence with the study requirements over the primary 3-6 month treatment period
Any condition or abnormality which may, in the opinion of the investigator, compromise the safety of patients
No condition or abnormality which may, in the opinion of the investigator, compromise the safety of the patient
Any condition or abnormality which may, in the opinion of the investigator, compromise the safety of patients
Serious concomitant systemic disorders (including active infections) that would compromise the safety of the patient or compromise the patient’s ability to complete the study, at the discretion of the investigator
Serious concomitant systemic disorders (including active infections or chronic infection requiring suppressive antibiotics) that would compromise the safety of the patient or compromise the patient’s ability to complete the study, at the discretion of the investigator
Concurrent severe or uncontrolled medical disease (i.e., active systemic infection, diabetes, coronary artery disease, congestive heart failure) that, in the opinion of the investigator, would compromise the safety of the patient or compromise the ability of the patient to complete the study
Any medical or psychiatric condition, illness, disorder, or concomitant medication that could compromise participant safety or treatment, as determined by the principal investigator and/or study physician
Any condition or abnormality which may, in the opinion of the investigator, compromise the safety of patients
Any condition or abnormality which may, in the opinion of the investigator, compromise the safety of the patient
Any condition or abnormality which may, in the opinion of the investigator, compromise the safety of patients
Any condition or abnormality which may, in the opinion of the investigator, compromise his or her safety
Any condition or abnormality which may, in the opinion of the investigator, compromise the safety of patients
Any condition or abnormality which may, in the opinion of the investigator, compromise the safety of the patient
Serious concomitant systemic disorders (including active infections) that would compromise the safety of the patient or compromise the patient’s ability to complete the study, at the discretion of the investigator, including active autoimmune disease requiring treatment within the past 30 days
Any other clinical condition that, in the Investigator's judgement, would potentially compromise study compliance or the ability to evaluate safety/efficacy
Serious concomitant systemic disorders (for example, active infection or abnormal electrocardiogram (ECG) indicative of cardiac disease) that, in the opinion of the investigator, would compromise the safety of the patient and his/her ability to complete the study
Any condition that may, in the opinion of the investigator, compromise the safety of the patient
Any condition or abnormality which may, in the opinion of the investigator, compromise the safety of patients
Any condition or abnormality which may, in the opinion of the investigator, compromise the safety of the patient
Presence of a condition or abnormality that in the opinion of the investigator would compromise the safety of the study participant or the quality of the study data
Any condition or behavior that in the judgment of the investigator, would compromise the patient’s ability to participate in the study and/or comply with study procedures
Serious concomitant systemic disorders (including active infections) that would compromise the safety of the patient or compromise the patient’s ability to complete the study, at the discretion of the investigator; this includes scleroderma
Any medical condition which, in the investigator's opinion, could compromise the patient's safety
Any medical condition that would compromise the subject’s ability to safely participate in the study
Previous medical history or evidence of an intercurrent illness that may, in the opinion of the investigator, compromise the safety of the patient in the study
Any condition or abnormality which may, in the opinion of the investigator, compromise the safety of patients
Serious concomitant systemic disorders (including active infections) that would compromise the safety of the patient or compromise the patient’s ability to complete the study, at the discretion of the investigator
Subjects with any other medical condition, which in the opinion of the investigator would compromise the results of the study by deleterious effects of treatment
Subjects with any other medical condition, which in the opinion of the investigator would compromise the results of the study by deleterious effects of treatment
Any serious or uncontrolled concomitant disorder that, in the opinion of the investigator, would compromise the patient’s ability to complete the study
Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the subject or the quality of the data.
Serious concomitant systemic disorders (e.g., active infection) that, in the opinion of the investigator, would compromise the safety of the patient or compromise the patient’s ability to complete the study
History of another malignancy that in the opinion of the investigator may compromise the outcome of the study
Any other condition, including concurrent medical condition, social circumstance or drug dependency, which in the opinion of the investigator could compromise patient safety and/or compliance with study requirements
No serious disease or condition that, in the opinion of the investigator, would compromise the patient’s ability to participate in the study
Any medical condition which, in the investigator's opinion, could compromise the patient's safety
Serious concomitant systemic disorder that would compromise the safety of the patient or compromise the patient’s ability to complete the study, at the discretion of the investigator
Any medical condition which, in the investigator's opinion, could compromise the patient's safety
Any condition or abnormality which may, in the opinion of the investigator, compromise his or her safety
Any condition or abnormality which may, in the opinion of the investigator, compromise the safety of patients
Any condition or abnormality which may, in the opinion of the investigator, compromise the safety of patients
Any condition or abnormality which may, in the opinion of the investigator, compromise the safety of the patient
Major surgery (other than definitive lung cancer surgery) within two weeks of study or other serious concomitant systemic disorders that, in the opinion of the investigator, would compromise the safety of the patient or compromise the patient’s ability to complete the study
Any other medical intervention or condition, which, in the opinion of the PI could compromise patient safety or adherence with the study requirements
Serious concomitant systemic disorders (including active infections) or psychiatric illness/social situations that would compromise the safety of the patient or compromise the patient’s ability to complete the study, at the discretion of the investigator
Any other medical condition that in the opinion of the principal investigator would compromise the ability to deliver or evaluate study drug
Any medical or psychiatric condition that in the opinion of the principal investigator would compromise the patient's ability to tolerate this treatment
Any other condition that, in the opinion of the investigator, may compromise the safety, compliance of the patient, or would preclude the patient from successful completion of the study
No serious disease or condition that, in the opinion of the investigator, would compromise the subject's ability to participate in the study
Previous medical history, or evidence, of an intercurrent illness that at the discretion of the principal investigator may compromise the safety of the subject in the study
Serious concomitant systemic disorders (including active infections) that would compromise the safety of the patient or compromise the patient’s ability to complete the study, at the discretion of the investigator; this includes scleroderma
Any condition or abnormality which may, in the opinion of the investigator, compromise the safety of patients
Has any other medical or personal condition that, in the opinion of the Investigator, may potentially compromise the safety or compliance of the patient, or may preclude the patient's successful completion of the clinical trial.
History of concomitant medical conditions or infectious diseases that, in the opinion of the investigator, would compromise the participant's ability to safely complete the study.
Any concurrent medical condition that, in the opinion of the Investigator, would complicate or compromise compliance with the study or the well-being of the subject
Serious concurrent medical illness that in the opinion of the investigator would compromise patient safety or preclude accurate assessment of outcome.
Serious concurrent psychiatric disorder that in the opinion of the investigator would compromise patient safety or preclude accurate assessment of outcome.
Concurrent severe or uncontrolled medical disease that would compromise the safety or compromise the ability of the patient to complete the study
Concurrent severe or uncontrolled medical disease that would compromise the safety or compromise the ability of the patient to complete the study
Concurrent severe or uncontrolled medical disease that would compromise the safety or compromise the ability of the patient to complete study
Serious concomitant systemic disorders (including active infections) that would compromise the safety of the patient or compromise the patient’s ability to complete the study, at the discretion of the investigator
Presence of a condition or abnormality that in the opinion of the investigator would compromise the safety of the patient or the quality of the data
Patient has a serious medical condition (e.g., stroke, liver or renal failure, congestive heart failure, myocardial infarction or cardiac surgery in past year, angina pectoris) that would compromise the safety of the patient or compromise the patient’s ability to complete the study, at the discretion of the investigator
Any condition, in the principal investigator’s opinion, that would compromise patient safety or study outcomes
Any autoimmune disease or other medical condition that, in the opinion of the investigator, would compromise the subject's safety
Any medical or psychiatric condition, illness, disorder, or concomitant medication that could compromise participant safety or treatment, as determined by the principal investigator or collaborator
Any medical or psychiatric condition, illness, disorder, or concomitant medication that could compromise participant safety or treatment, as determined by the principal investigator
Any medical or psychiatric condition, illness, disorder, or concomitant medication that could compromise participant safety or treatment, as determined by the principal investigator and/or study physician
Any condition or abnormality which may, in the opinion of the investigator, compromise the safety of patients
Any condition or abnormality which may, in the opinion of the investigator, compromise the safety of patients
Has signs, symptoms or history of any condition that, per protocol or in the opinion of the investigator, might compromise:
Have any condition that, in the opinion of the investigator, would compromise the well-being of the subject or the study or prevent the subject from meeting or performing study requirements
Have any condition that, in the opinion of the investigator, would compromise the well-being of the subject or the study or prevent the subject from meeting or performing study requirements
Have any condition that, in the opinion of the investigator, would compromise the well-being of the subject or the study or prevent the subject from meeting or performing study requirements
Has any condition that, in the opinion of the investigator, would compromise the well-being of the participant or the study or prevent the participant from meeting or performing study requirements
Any condition that in the opinion of the principal investigator, would compromise the well-being of the subject or the study or prevent the subject from meeting or performing the study requirements
Have any condition that, in the opinion of the investigator, would compromise the well-being of the subject or the study or prevent the subject from meeting or performing study requirements
Have any condition that, in the opinion of the investigator, would compromise the well-being of the subject or the study or prevent the subject from meeting or performing study requirements
Have any condition that, in the opinion of the investigator, would compromise the well-being of the subject or the study or prevent the subject from meeting or performing study requirements
Have any condition that, in the opinion of the investigator, would compromise the well-being of the subject or the study or prevent the subject from meeting or performing study requirements
Patients with any condition that, in the opinion of the investigator, would compromise the well-being of the subject or the study or prevent the subject from meeting or performing study requirements
Any condition that, in the opinion of the investigator, would compromise the well-being of the participant or the study or prevent the participant from meeting or performing study requirements OEP phase:
Have any condition that, in the opinion of the investigator, would compromise the well-being of the subject or the study or prevent the subject from meeting or performing study requirements
Have any condition that, in the opinion of the investigator, would compromise the well-being of the subject or the study or prevent the subject from meeting or performing study requirements
Serious or unstable medical or psychological conditions that, in the opinion of the investigator would compromise the subject’s safety or successful participation in the study
Serious or unstable medical or psychological conditions that, in the opinion of the investigator, would compromise the subject’s safety or successful participation in the study
Serious or unstable medical or psychological conditions that, in the opinion of the investigator would compromise the subject’s safety or successful participation in the study
Serious or unstable medical or psychological conditions that, in the opinion of the investigator, would compromise the subject’s safety or successful participation in the study
Serious or unstable medical or psychological conditions that, in the opinion of the investigator, would compromise the subject’s safety or successful participation in the study
Serious or unstable medical or psychological conditions that, in the opinion of the investigator would compromise the subject’s safety or successful participation in the study
Serious or unstable medical or psychological comorbidities that, in the opinion of the investigator, would compromise the subject’s safety or successful participation in the study
Serious or unstable medical or psychological conditions that, in the opinion of the investigator, would compromise the subject’s safety or successful participation in the study
Life-threatening illness or organ system dysfunction compromising safety evaluation
Any life-threatening illness, medical condition, or organ system dysfunction that, in the investigator’s opinion, could compromise the subject’s safety or put the study outcomes at undue risk
Any life-threatening illness, medical condition, or organ system dysfunction that, in the investigator’s opinion, could compromise the subject’s safety or put the study outcomes at undue risk
Any life-threatening illness, medical condition, or organ system dysfunction that, in the opinion of the investigator, could compromise the subject’s safety or put the study outcomes at undue risk
Any life-threatening illness, medical condition, or organ system dysfunction that, in the investigator's opinion, could compromise the subject's safety or put the study outcomes at undue risk
Subjects with life-threatening illnesses other than MDS, uncontrolled medical conditions or organ system dysfunction which, in the investigator’s opinion, could compromise the subject’s safety, or put the study outcomes at risk
Any life-threatening illness, medical condition, or organ system dysfunction that, in the investigator’s opinion, could compromise the subject’s safety or put the study outcomes at undue risk
Any life-threatening illness, medical condition or organ system dysfunction which, in the investigator's opinion, could compromise the patient’s safety
Any life threatening illness, medical condition, or organ system dysfunction that, in the investigator’s opinion, could compromise the subject’s safety or put the study outcomes at undue risk
Any life-threatening illness, medical condition, or organ system dysfunction that, in the investigator's opinion, could compromise the subject's safety or put the study outcomes at undue risk
Any life-threatening illness, medical condition, or organ system dysfunction that, in the investigator's opinion, could compromise the subject's safety or put the study outcomes at undue risk
Any life-threatening illness, medical condition, or organ system dysfunction that, in the investigators’ opinion, could compromise the subject’s safety or put the study outcomes at undue risk
Any life-threatening illness, known autoimmune disease, medical condition, or organ system dysfunction that, in the investigator’s opinion, could compromise the subject’s safety or put the study outcomes at undue risk
Any life-threatening illness, medical condition, or organ system dysfunction that, in the investigator's opinion, could compromise the subject's safety or put the study outcomes at undue risk
Any life-threatening illness, medical condition, or organ system dysfunction that, in the investigator’s opinion, could compromise the subject’s safety or put the study outcomes at undue risk
Current life-threatening illness, medical condition, or organ-system dysfunction that could compromise patient safety or put the study at risk
Researchers think that any life-threatening illness, condition or organ system dysfunction can damage the safety of subjects
Any life-threatening illness, medical condition, or organ system dysfunction, including but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, active autoimmune disorder, or psychiatric illness/social situations that, in the investigator’s opinion, could compromise the subject’s safety or put the study outcomes at undue risk
Subjects with a life-threatening illness, medical condition or organ system dysfunction, or other reasons which, in the investigator’s opinion, could compromise the subject’s safety, interfere with or compromise the integrity of the study outcomes including incomplete recovery from the acute effects from any prior anti-neoplastic therapy
Current life-threatening illness, medical condition, or organ system dysfunction, which, in the investigator’s opinion, could compromise the patient’s safety, or put the study at risk
Any life-threatening illness, medical condition, or organ system dysfunction that, in the investigator’s opinion, could compromise the patient’s safety, or put the study at undue risk; patients with suspicious radiologic evidence of aspergillosis infection (i.e., chest computed tomography [CT] and/or brain magnetic resonance imaging [MRI]) will not be eligible unless confirmatory laboratory testing of beta-D glucan and aspergillus antigen are negative
Any life-threatening illness, medical condition, or organ system dysfunction that, in the investigator’s opinion, could compromise the patient’s safety, or put the study at undue risk
Any life-threatening illness, medical condition, or organ system dysfunction that, in the investigator’s opinion, could compromise the subject’s safety or put the study outcomes at undue risk
Any life-threatening illness, medical condition, or organ system dysfunction that, in the investigator’s opinion, could compromise the subject’s safety or put the study outcomes at undue risk
Any life-threatening illness, medical condition, organ system dysfunction, need for profound anticoagulation, or bleeding disorder, which, in the investigator's opinion, could compromise the subject's safety
A life-threatening illness, medical condition (including psychiatric conditions) or organ system dysfunction which, in the investigator's opinion, could compromise the subject's safety
Any life-threatening illness, medical condition or organ system dysfunction which, in the investigator's opinion, could compromise the subject's safety or put the study outcomes at undue risk
Any life-threatening illness, medical condition, or organ system dysfunction that, in the investigator's opinion, could compromise the subject's safety or put the study outcomes at undue risk.
Any life-threatening illness, medical condition, or organ system dysfunction that, in the opinion of the investigator, could compromise the subject's safety or put the study outcomes at undue risk
Current life-threatening illness, medical condition, or organ system dysfunction which, in the investigator’s opinion, could compromise the patient’s safety, or put the study at risk
Life-threatening illnesses other than AML, uncontrolled medical conditions or organ system dysfunction that, in the Investigator's opinion, could compromise the patient's safety or put the study outcomes at risk
Any life-threatening illness, medical condition, including uncontrolled diabetes mellitus (DM), or organ system dysfunction that, in the opinion of the investigator, could compromise the subject's safety or put the study outcomes at undue risk
Any life-threatening illness, medical condition, or organ system dysfunction that, in the investigator's opinion, could compromise the subject's safety or put the study outcomes at undue risk.
Current life-threatening illness, medical condition, or organ system dysfunction which, in the Investigator’s opinion, could compromise the patient’s safety, or put the study at risk
Presence of a life-threatening illness, medical condition, organ system dysfunction, or other factors
Life-threatening illness or organ system dysfunction compromising safety evaluation
Any life-threatening illness, medical condition, or organ system dysfunction which, in the investigator’s opinion, could compromise the subject’s safety or put the study outcomes at undue risk
Any life-threatening illness, medical condition, or organ system dysfunction that, in the investigator’s opinion, could compromise the subject’s safety or put the study outcomes at undue risk
Any life-threatening illness, medical condition, or organ system dysfunction that, in the investigator’s opinion, could compromise the subject’s safety or put the study outcomes at undue risk
Patient has a life-threatening illness, medical condition, or organ system dysfunction that, in the opinion of the investigator, could compromise the subject’s safety or put the study outcomes at undue risk
EXCLUSION CRITERIA (PRIOR TO IBRUTINIB ADMINISTRATION): Any life threatening illness, medical condition, or organ system dysfunction that, in the investigator’s opinion, could compromise the subject’s safety or put the study outcomes at undue risk
Life-threatening illnesses other than AML or MDS, uncontrolled medical conditions or organ system dysfunction which, in the investigator's opinion, could compromise the patient's safety, or put the study outcomes at risk.
Other serious, ongoing, non-malignant disease or infection that would compromise protocol objectives
Serious nonmalignant disease (e.g., hydronephrosis, liver failure, or other conditions) that could compromise protocol objectives in the opinion of the investigator and/or the sponsor
Medical or psychiatric illnesses that, in the investigator's opinion, may impact the safety of the subject or the objectives of the study.
Serious non-malignant disease that could compromise protocol objectives in the opinion of the Investigator and/or the Sponsor.
Subject requires any medical intervention(s) or has any other condition(s) that, in the Investigator’s opinion, will 1) make the administration of PROSTVAC or ipilimumab hazardous, 2) obscure the interpretation of adverse events (AEs), 3) compromise adherence with study requirements, or 4) otherwise compromise the study’s objectives
Any medical intervention, any other condition, or any other circumstance which, in the opinion of the investigator, could compromise adherence with study requirements or otherwise compromise the study’s objectives
Serious non-malignant disease such as active infection or other condition which in the opinion of the investigator would compromise other protocol objectives
Any medical intervention or other condition which, in the opinion of the principal investigator, could compromise adherence with study requirements or otherwise compromise the study’s objectives
Significant acute or chronic medical or psychiatric illness that, in the judgment of the Investigator, could compromise subject safety, limit the subject's ability to complete the trial, and/or compromise the objectives of the trial
Serious, ongoing, non-malignant disease or infection, which in the opinion of the investigator and/or the sponsor would compromise other protocol objectives; participants with active opportunistic infections are ineligible
Serious nonmalignant disease that could compromise protocol objectives in the opinion of the investigator and/or the sponsor
Serious nonmalignant disease (e.g., hydronephrosis, liver failure, or other conditions) that could compromise protocol objectives in the opinion of the investigator
Other serious, ongoing, non-malignant disease or infection that would in the opinion of the site investigator compromise other protocol objectives
hepatic, renal neurological or metabolic conditions - which in the opinion of the investigator would compromise the protocol objectives.
Any concomitant condition that in the opinion of the investigator could compromise the objectives of this study and the patient's compliance.
Any other condition or circumstance that could interfere with adherence to the study’s procedures or requirements, or otherwise compromise the study’s objectives such as history of, or any evidence of active, non-infectious pneumonitis
Any other current or previous malignancy within the past three years that, in the opinion of the Principal Investigator, will interfere with study-specific objectives.
Any serious medical or psychiatric illness, including drug or alcohol abuse that could, in the investigator's opinion, potentially jeopardize the safety of the participant or interfere with the objectives of the study.
Significant acute or chronic medical, neurologic, or psychiatric illness in the subject that, in the judgment of the principal investigator, could compromise subject safety, limit the subject’s ability to complete the study, and/or compromise the objectives of the study
Any concomitant condition that in the opinion of the Investigator could compromise the objectives of this study and the patient's compliance.
Other condition(s) that in the opinion of the investigator might compromise the objectives of the study
Serious nonmalignant disease which, in the opinion of the investigator would compromise protocol objectives
Patients or their representative who are unable to understand the conditions and objectives of the study
Current or prior disease or treatment that could compromise protocol objectives in the opinion of the Investigator and/or the Sponsor
Other condition(s) that in the opinion of the investigator might compromise the objectives of the study or increase patient risk
Any medical intervention or other condition which, in the opinion of the principal investigator could compromise adherence with study requirements or otherwise compromise the study's objectives
Serious, ongoing, non-malignant disease or infection, which in the opinion of the investigator and/or the sponsor would compromise other protocol objectives; participants with active opportunistic infections are ineligible
Any condition that compromises compliance with the objectives and procedures of this protocol
Serious nonmalignant disease (e.g., hydronephrosis, liver failure, or other conditions) that could compromise protocol objectives in the opinion of the investigator and/or the sponsor.
Any medical intervention or other condition which, in the opinion of the principal investigator could compromise adherence with study requirements or otherwise compromise the study’s objectives
Any concomitant condition that in the opinion of the investigator could compromise the objectives of this study and the patient's compliance.
Serious non-malignant disease (e.g., active uncontrolled bacterial, viral, or fungal infections) or other medical conditions (including psychiatric) which, in the opinion of the Principal Investigator (PI) would compromise other protocol objectives
Serious nonmalignant or malignant disease or psychiatric illness, which, in the opinion of the investigator would compromise protocol objectives or interfere with participation
Have active infection that would interfere with the study objectives or influence study compliance
Any medical intervention, condition or any other circumstance which in the opinion of the investigator or the sponsor's medical monitor, could compromise adherence to study procedures or study objectives.
Serious nonmalignant disease (e.g., hydronephrosis, liver failure, heart failure, or other conditions) that could compromise protocol objectives in the opinion of the investigator and/or the sponsor.
Active alcohol abuse or other illness or circumstance that carries a likelihood of inability to comply with study treatment and follow-up or otherwise compromise the study’s objectives
Serious nonmalignant disease (e.g., hydronephrosis, liver failure, or other conditions) that could compromise protocol objectives in the opinion of the investigator and/or the sponsor.
Patients may not have any concomitant condition that could compromise the objectives of this study and the patients' compliance and ability to tolerate this therapy and complete at least 2 cycles of therapy, including, but not limited to the following:
Serious nonmalignant disease (e.g., congestive heart failure, hydronephrosis); active uncontrolled bacterial, viral, or fungal infections; or other conditions which would compromise protocol objectives in the opinion of the investigator
Has a medical or psychiatric condition or other circumstances which would significantly decrease the chances of obtaining reliable data, achieving study objectives, or completing the study and/or post-dose follow-up examinations.
Medical exclusions include: patients with a history of myocardial infarction or ischemic heart disease within the past six months; patients with history of epilepsy, brain damage, or symptomatic brain metastases; skin conditions such as open sores that would prevent proper application of the electrodes; or other medical or other condition(s) that in the opinion of the investigators might compromise the objectives of the study
Other medical or other condition(s) that in the opinion of the investigators might compromise the objectives of the study
Significant acute or chronic medical, neurologic, or psychiatric illness in the subject that, in the judgment of the principal investigator, could compromise subject safety, limit the subject’s ability to complete the study, and/or compromise the objectives of the study
Other medical or other condition(s) that in the opinion of the investigators might compromise the objectives of the study
Other medical or other condition(s) that in the opinion of the investigators might compromise the objectives of the study
Other medical or other condition(s) that in the opinion of the investigators might compromise the objectives of the study
Any medical condition or other circumstances that in the opinion of the investigators compromise obtaining reliable data or achieving the study objectives
Subjects with any medical condition or other circumstance that, in the opinion of the investigator, compromise obtaining reliable data, achieving study objectives, or completion. Cohort A Only:
Have a medical condition or other circumstances that, in the opinion of the investigator would significantly decrease the chances of obtaining reliable data, achieving the study objectives, or completing the trial.
Inclusion Criteria:\n\n 1. Patients with selected solid malignancies (NSCLC, SCLC, SqCCHN, melanoma, merkel cell\n tumor, renal, bladder, hepatocellular, triple negative breast, or gastroesophageal\n cancer) or Hodgkin's lymphoma\n\n 2. At least 1 measurable lesion documented on CT/MRI (RECIST criteria 1.1)\n\n 3. Eastern Cooperative Oncology Group (ECOG) performance status ? 2 (Appendix B: ECOG\n Scoring)\n\n 4. Age ? 18 years\n\n 5. Ability to understand the purposes and risks of the trial and has signed a\n IRB-approved informed consent form\n\n 6. Willingness and ability to comply with all protocol required procedures\n\n 7. For men and women of child-bearing potential, use of effective contraceptive methods\n during the study\n\n Exclusion Criteria:\n\n Patients meeting any of the following criteria will not be eligible for study entry:\n\n 1. Known infection with human immunodeficiency virus (HIV)\n\n 2. Serious nonmalignant disease or conditions that in the opinion of the investigator\n and/or ImaginAb could compromise protocol objectives\n\n 3. Patients who have had splenectomy.\n\n 4. Patients who have any splenic disorders that in the opinion of the investigator and/or\n ImaginAb could compromise protocol objectives.\n\n 5. Patients who are currently receiving any other investigational agent\n\n 6. Pregnant women or nursing mothers\n\n 7. Hepatic laboratory values:\n\n 1. Bilirubin > 1.5 x ULN (institutional upper limits of normal)\n\n 2. Albumin < 2 g/dL\n\n 3. Other local safety laboratory test results (clinical chemistry and hematology)\n are determined to be exclusionary by the Investigator.\n\n 8. Known sensitivity to glutamic acid or glutamate.
Have any medical condition or other circumstances that, in the opinion of the investigator, would significantly decrease obtaining reliable data, achieving study objectives or completing the study
Has any other medical condition or other circumstances that would significantly decrease the chances of obtaining reliable data or of achieving the study objectives such as:\r\n* Mental illness\r\n* Drug abuse
Any medical condition that in the opinion of the investigators could potentially jeopardize the safety of the patient, limit the patient’s ability to complete the study, and/or compromise the objectives of the study
Have a medical condition or other circumstances which, in the opinion of the investigator would significantly decrease the chances of obtaining reliable data, achieving the study objectives, or completing the study.
Have a medical condition or other circumstances that, in the opinion of the investigator would significantly decrease the chances of obtaining reliable data, achieving the study objectives, or completing the trial.
Significant acute or chronic medical, neurologic, or psychiatric illness in the subject that, in the judgment of the investigator, could compromise subject safety, limit the subject’s ability to complete the study, and/or compromise the objectives of the study